EN ISO 24443:2012
(Main)Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2012)
Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2012)
ISO 24443:2012 specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide a UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. This method relies on the use of in vivo SPF results for scaling the UV absorbance curve.
In vitro Bestimmung des UVA-Schutzes von Sonnenschutzmitteln (ISO 24443:2012)
Diese Internationale Norm stellt ein in vitro Verfahren zur Charakterisierung des UVA-Schutzes von Sonnenschutzmitteln dar. Es werden Spezifikationen angegeben, für eine reproduzierbare Bestimmung der spektralen Extinktion als Charakterisierung des UVA-Schutzes.
Zur Bestimmung der relevanten Kenngrößen für den UVA-Schutz wird die Kurve der spektralen Extinktion im UV ermittelt, auf deren Grundlage eine Reihe von Berechnungen und Bewertungen vorgenommen werden können. Ergebnisse dieses Messverfahrens können für weitere Berechnungen, wie zum Beispiel für örtliche Aufsichtsbehörden, verwendet werden. Dies beinhaltet die Berechnung des UVA-Schutzfaktors (UVAPF) [korreliert mit dem in vivo UVA-Schutzfaktor aus dem Persistent Pigment Darkening-Prüfverfahren (PPD)], der kritischen Wellenlänge und des UVA-/UVB-Extinktionsverhältnisses. Diese Berechnungen sind optional und beziehen sich auf die örtlichen Anforderungen zur Kennzeichnung von Sonnenschutzmitteln. Diese Methode basiert auf der Verwendung der in vivo SPF-Ergebnisse für die Skalierung der UV-Extinktionskurve.
Diese Internationale Norm gilt nicht für pulverförmige Produkte, die zum Beispiel gepresst oder lose vorliegen.
Détermination in vitro de la photoprotection UVA (ISO 24443:2012)
L'ISO 24443:2012 d'essai spécifie un mode opératoire in vitro pour caractériser la protection UVA apportée par des produits de protection solaire. Des spécifications sont données pour permettre de déterminer les caractéristiques d'absorbance spectrale de la protection UVA de façon reproductible.
Afin de déterminer les paramètres de protection UVA pertinents, la méthode a été mise au point pour fournir une courbe d'absorbance spectrale UV à partir de laquelle des calculs et des évaluations peuvent être effectués. Cette méthode repose sur les résultats du FPS in vivo pour élaborer la courbe d'absorbance des UV.
Kozmetika - Določevanje zaščitnega faktorja UVA in vitro (ISO 24443:2012)
Ta preizkusna metoda zagotavlja postopek in vitro za zaščito pred žarki UVA varovalnih sredstev za zaščito kože pred soncem. Podane specifikacije omogočajo določitev lastnosti spektralne absorpcije zaščite pred žarki UVA na ponovljiv način. Za določitev ustreznih parametrov zaščite pred žarki UVA je bila ustvarjena metoda za zagotovitev krivulje spektralne absorpcije UV, iz katere je mogoče izpeljati številne izračune in ocene. Rezultati tega postopka merjenja se lahko po potrebi uporabijo za druge izračune za lokalne regulativne organe. Ti vključujejo izračun ultravijoličnega A zaščitnega faktorja (UVA-PF) (ki se navezuje na UVA-PF in vivo iz preizkusnega postopka obstojne pigmentacije), kritične valovne dolžine in razmerja absorpcije žarkov UVA/UVB. Ti izračuni so izbirni in se nanašajo na zahteve glede označevanja izdelkov za zaščito kože pred soncem.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2012
.R]PHWLND'RORþHYDQMH]DãþLWQHJDIDNWRUMD89$LQYLWUR ,62
Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2012)
In vitro Bestimmung des UVA-Schutzes von Sonnenschutzmitteln (ISO 24443:2012)
Détermination in vitro de la photoprotection UVA (ISO 24443:2012)
Ta slovenski standard je istoveten z: EN ISO 24443:2012
ICS:
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 24443
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2012
ICS 71.100.70
English Version
Determination of sunscreen UVA photoprotection in vitro (ISO
24443:2012)
Détermination in vitro de la photoprotection UVA (ISO In vitro Bestimmung des UVA-Schutzes von
24443:2012) Sonnenschutzmitteln (ISO 24443:2012)
This European Standard was approved by CEN on 24 May 2012.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24443:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 24443:2012) has been prepared by Technical Committee ISO/TC 217 "Cosmetics" in
collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by December 2012, and conflicting national standards shall be withdrawn
at the latest by December 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 24443:2012 has been approved by CEN as a EN ISO 24443:2012 without any modification.
INTERNATIONAL ISO
STANDARD 24443
First edition
2012-06-01
Determination of sunscreen UVA
photoprotection in vitro
Détermination in vitro de la photoprotection UVA
Reference number
ISO 24443:2012(E)
©
ISO 2012
ISO 24443:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
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Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 24443:2012(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Terms and definitions . 1
3 Principle . 2
4 Apparatus . 2
4.1 UV spectrophotometer specifications . 2
4.2 Calibration of the UV spectrophotometer . 3
4.3 Calibration of the UV exposure source . 3
4.4 Monitoring of the UV exposure source . 3
4.5 Calibration of the UVA radiometer used to monitor the test sample irradiation . 4
4.6 Substrate/plate . 4
5 Test method . 4
5.1 Outline of the test procedure . 4
5.2 Equipment calibration and validation of test plates . 4
5.3 Absorption measurements through the plate . 5
5.4 Sample application . 5
5.5 Absorbance measurements of the product-treated plate . 5
5.6 Number of determinations . 5
5.7 Determination of initial calculated SPF (SPF ), “C” value, initial UVAPF(UVAPF ), and UV
in vitro 0
exposure dose . 5
5.8 UV exposure . 7
5.9 Measurement of final adjusted absorbance spectrum . 7
5.10 Calculation of UVAPF of plates after UV exposure of the sample . 8
6 Procedure using the spreadsheet in this International Standard . 8
7 Reference sunscreen formula S2 . 9
8 Test report . 9
Annex A (normative) Calibration of UV spectrophotometer and plate transmission test .10
Annex B (normative) Radiometer calibration to spectroradiometric irradiance procedure .14
Annex C (normative) Computation values: PPD and erythema action spectra and UVA and UV-SSR
spectral irradiances .16
Annex D (normative) PMMA test plate surface specifications .19
Annex E (normative) UVA reference sunscreen S2 .21
Annex F (informative) Statistical calculations .25
Bibliography .27
ISO 24443:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
iv © ISO 2012 – All rights reserved
INTERNATIONAL STANDARD ISO 24443:2012(E)
Determination of sunscreen UVA photoprotection in vitro
1 Scope
This International Standard specifies an in vitro procedure to characterize the UVA protection of sunscreen
products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA
protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide a UV spectral
absorbance curve from which a number of calculations and evaluations can be undertaken. Results from
this measurement procedure can be used for other computations, as required by local regulatory authorities.
These include calculation of the Ultraviolet-A protection factor (UVAPF) [correlating with in vivo UVAPF
from the persistent pigment darkening (PPD) testing procedure], critical wavelength and UVA absorbance
proportionality. These computations are optional and relate to local sunscreen product labelling requirements.
This method relies on the use of in vivo SPF results for scaling the UV absorbance curve.
This International Standard is not applicable to powder products such as pressed powder and loose powder products.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
in vitro UVA protection factor
UVAPF
in vitro UVA protection factor of a sun protection product against UVA radiation, which can be derived
mathematically with in vitro spectral modelling
2.2
in vitro calculation of SPF
SPF
in vitro
protection factor of a sun protection product against erythema-inducing radiation calculated with spectral modelling
2.3
action spectrum for erythema
E(l)
relative effects of individual spectral bands of an exposure source for an erythema response
NOTE See References [1] and [2].
2.4
action spectrum for PPD
P(l)
relative effects of individual spectral bands of an exposure source for a persistent pigment response
NOTE See References [3] and [4].
2.5
monochromatic absorbance
A
l
sunscreen absorbance at wavelength, l, related to the sunscreen transmittance, T , by
l
A = - log (T )
l l
where transmittance, T , is the fraction of incident irradiance transmitted by the sunscreen film
l
ISO 24443:2012(E)
2.6
irradiance
I
fluence rate per unit area, expressed in W/m , for a defined range of wavelengths
EXAMPLE From 290 nm to 400 nm for UVA + UVB irradiance; from 320 nm to 400 nm for UVA irradiance.
2.7
spectral irradiance for SPF testing or PPD testing
I(l)
irradiance per unit wavelength, I(l) , expressed in W/m /nm
2.8
spectrophotometer
instrument that measures absorbance (or transmission) properties of a test medium as a function of wavelength
2.9
spectroradiometer
instrument that measures spectral irradiance (intensity in watts per unit area per nanometre) of
electromagnetic source
...
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